Ensitrelvir FDA Approval Status

Last updated by Judith Stewart, BPharm on July 14, 2025.

FDA Approved: No
Generic name: ensitrelvir
Company: Shionogi Inc.
Treatment for: Post-Exposure Prophylaxis of COVID-19

Ensitrelvir is a 3CL protease inhibitor antiviral in development for post-exposure prophylaxis of COVID-19.

COVID-19 continues to pose a health risk for many people, and additional treatment and preventive options are needed. If approved, ensitrelvir is expected to be the first orally-administered option for the post-exposure prophylaxis of COVID-19.
Ensitrelvir works in the prophylaxis of COVID-19 by suppressing the replication of the SARS-CoV-2 virus through selective inhibition of the 3CL protease enzyme.
A New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for ensitrelvir for post-exposure prophylaxis of COVID-19 based on positive results from the Global Phase 3 Study, Stopping COVID-19 pRogression with early Protease InhibitOr treatment – Post-Exposure Prophylaxis (SCORPIO-PEP).
Ensitrelvir was granted Fast Track designation by the FDA in 2025 for post-exposure prophylaxis of COVID-19 following contact with an individual who has COVID-19, and was granted Fast Track designation by the FDA in 2023 for the treatment of COVID-19.

Development timeline for ensitrelvir

Date	Article
Mar 31, 2025	Shionogi Initiates New Drug Application Submission for Ensitrelvir for Post-Exposure Prophylaxis with the U.S. Food and Drug Administration
Mar 13, 2025	SCORPIO-PEP Phase 3 Trial: Ensitrelvir is the First and Only COVID-19 Oral Antiviral to Demonstrate Prevention of COVID-19 as Post Exposure Prophylaxis
Apr 4, 2023	Shionogi Receives U.S. FDA Fast Track Designation for Ensitrelvir Fumaric Acid, an Investigational Oral Antiviral for COVID-19

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